The acquisition expands Organon’s dermatology
capabilities with a nonbiologic, non-steroidal topical treatment in
the U.S.
Organon (NYSE: OGN), a global healthcare company with a mission
to improve the health of women throughout their lives, today
announced the successful completion of its acquisition of Dermavant
Sciences Ltd. from Roivant (NASDAQ: ROIV). Dermavant is a company
dedicated to developing and commercializing innovative therapeutic
solutions in immuno-dermatology. Please see our prior announcement
for a summary of the transaction terms.
VTAMA® (tapinarof) cream, 1%, is a novel nonbiologic,
non-steroidal topical therapy approved by the U.S. Food and Drug
Administration (FDA) for treatment of mild, moderate, and severe
plaque psoriasis in adults with no safety label warnings or
precautions and without restrictions on location and duration of
use or body surface area. The FDA is reviewing a supplemental New
Drug Application (sNDA) for VTAMA cream as a potential treatment
for atopic dermatitis (AD) in adults and children two years of age
and older, with Prescription Drug User Fee Act (PDUFA) action
expected in the fourth quarter of calendar year 2024.
Plaque psoriasis and atopic dermatitis-commonly known as
eczema-are common chronic inflammatory skin diseases affecting
millions of people in the U.S. and around the globe.1,2 Psoriasis
presents a significant impact to quality of life and atopic
dermatitis is associated with a higher disease burden for women
compared to men.3,4
“The future of dermatology depends on innovative treatments like
VTAMA, and Organon’s acquisition of Dermavant allows us to further
expand our existing portfolio of established brands and biosimilar
dermatology treatments,” said Kevin Ali, Chief Executive Officer of
Organon. “Integrating the expertise of Dermavant into Organon’s
U.S. organization marks the beginning of a new chapter in
dermatology. We are excited to bring this nonbiologic non-steroidal
topical option to the millions of patients suffering from a chronic
skin condition like plaque psoriasis and, potentially in the
future, atopic dermatitis.”
“I would like to thank Kevin and the entire Organon team for
their partnership in the acquisition of Dermavant,” said Mayukh
Sukhatme, MD, President and Chief Investment Officer of Roivant.
“This deal represents a true win-win outcome for Organon and
Roivant in our mutual goal to address patient needs and is
emblematic of Roivant’s ability to form non-traditional,
value-enhancing collaborations on important medicines. We believe
that Organon’s strong global commercial footprint will maximize the
impact of VTAMA for patients globally, and we are excited to
continue to share meaningfully in the success of VTAMA along the
way.”
About VTAMA® (tapinarof) cream, 1%
VTAMA cream is a non-steroidal once-daily topical treatment. The
safety and effectiveness of VTAMA cream was evaluated in
randomized, double-blind, vehicle-controlled trials, PSOARING-1 and
2 for plaque psoriasis. The safety and efficacy of VTAMA for the
treatment of atopic dermatitis was also evaluated in ADORING-1 and
ADORING-2 Phase III clinical studies and is currently under review
with the FDA.
Important Safety Information
Indication: VTAMA® (tapinarof) cream, 1% is an aryl
hydrocarbon receptor agonist indicated for the topical treatment of
plaque psoriasis in adults. VTAMA cream is for use on the skin
(topical) only. Do not use VTAMA cream in your eyes, mouth, or
vagina. Adverse Events: The most common adverse reactions
(incidence ≥ 1%) in subjects treated with VTAMA cream were
folliculitis (red raised bumps around the hair pores),
nasopharyngitis (pain or swelling in the nose and throat), contact
dermatitis (skin rash or irritation, including itching and redness,
peeling, burning, or stinging), headache, pruritus (itching), and
influenza (flu).
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
See full Prescribing Information and Patient Information.
About Organon
Organon is an independent global healthcare company with a
mission to help improve the health of women throughout their lives.
Organon’s diverse portfolio offers more than 60 medicines and
products in women’s health, biosimilars, and a large franchise of
established medicines across a range of therapeutic areas. In
addition to Organon’s current products, the company invests in
innovative solutions and research to drive future growth
opportunities in women’s health and biosimilars. In addition,
Organon is pursuing opportunities to collaborate with
biopharmaceutical partners and innovators looking to commercialize
their products by leveraging its scale and agile presence in fast
growing international markets.
Organon has geographic scope with significant reach, world-class
commercial capabilities, and approximately 10,000 employees with
headquarters located in Jersey City, New Jersey.
For more information, visit http://www.organon.com and connect
with us on LinkedIn, Instagram, X (formerly known as Twitter) and
Facebook.
Cautionary Note Regarding Forward-Looking Statements
Except for historical information, this press release includes
“forward-looking statements” within the meaning of the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995, including, but not limited to, statements about management’s
expectations about Organon’s acquisition of Dermavant (including
statements regarding the timing, benefits, and financial impact of
such acquisition), potential regulatory approvals and other actions
relating to VTAMA (including the expected timeframe thereof), and
Organon’s expected financial results and condition. Forward-looking
statements may be identified by words such as “pursuing,”
“foresees,” “future,” “potential,” “potentially,” “expected,”
“expects,” “will” or words of similar meaning. These statements are
based upon the current beliefs and expectations of Organon’s
management and are subject to significant risks and uncertainties.
If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.
Risks and uncertainties include, but are not limited to, an
inability to execute on our business development strategy or
realize the benefits of our acquisition of Dermavant or any other
planned acquisitions; weakening of economic conditions that could
adversely affect the level of demand for Dermavant’s products; the
risk that the business will not be integrated successfully; risks
related to the ability to realize the anticipated benefits of the
acquisition, including the possibility that the expected benefits
from the acquisition will not be realized or will not be realized
within the expected time period; the ability to retain key
personnel; unknown liabilities; the risk of litigation and/or
regulatory actions related to the completed acquisition; pricing
pressures globally, including rules and practices of managed care
groups, judicial decisions and governmental laws and regulations
related to Medicare, Medicaid and health care reform,
pharmaceutical reimbursement and pricing in general; an inability
to fully execute on Organon’s product development and
commercialization plans in the United States, Europe, and elsewhere
internationally; an inability to adapt to the industry-wide trend
toward highly discounted channels; changes in tax laws or other tax
guidance which could adversely affect Organon’s cash tax liability,
effective tax rates, and results of operations and lead to greater
audit scrutiny; expanded brand and class competition in the markets
in which Organon operates; and governmental initiatives that
adversely impact Organon’s marketing activities. Organon undertakes
no obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or otherwise.
Additional factors that could cause results to differ materially
from those described in the forward-looking statements can be found
in Organon’s filings with the Securities and Exchange Commission
(“SEC”), including Organon’s most recent Annual Report on Form 10-K
and subsequent SEC filings, available at the SEC’s Internet site
www.sec.gov. References and links to websites have been provided
for convenience, and the information contained on any such website
is not a part of, or incorporated by reference into, this press
release. Organon is not responsible for the contents of third-party
websites
About Roivant
Roivant is a biopharmaceutical company that aims to improve the
lives of patients by accelerating the development and
commercialization of medicines that matter. Roivant’s pipeline
includes IMVT-1402 and batoclimab, fully human monoclonal
antibodies targeting FcRn in development across several
IgG-mediated autoimmune indications; brepocitinib, a potent small
molecule inhibitor of TYK2 and JAK1 in development for the
treatment of dermatomyositis and non-infectious uveitis; and
mosliciguat, an inhaled soluble sGC activator in development for
pulmonary hypertension associated with interstitial lung disease,
in addition to other clinical stage molecules. We advance our
pipeline by creating nimble subsidiaries or “Vants” to develop and
commercialize our medicines and technologies. Beyond therapeutics,
Roivant also incubates discovery-stage companies and health
technology startups complementary to its biopharmaceutical
business. For more information, www.roivant.com.
Roivant Forward-Looking Statements
This press release contains forward-looking statements.
Statements in this press release may include statements that are
not historical facts and are considered forward-looking within the
meaning of Section 27A of the Securities Act of 1933, as amended
(the “Securities Act”), and Section 21E of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), which are usually
identified by the use of words such as “anticipate,” “believe,”
“continue,” “could,” “estimate,” “expect,” “intends,” “may,”
“might,” “plan,” “possible,” “potential,” “predict,” “project,”
“should,” “would” and variations of such words or similar
expressions. The words may identify forward-looking statements, but
the absence of these words does not mean that a statement is not
forward-looking. We intend these forward-looking statements to be
covered by the safe harbor provisions for forward-looking
statements contained in Section 27A of the Securities Act and
Section 21E of the Exchange Act.
Our forward-looking statements include, but are not limited to,
statements regarding our or our management team’s expectations,
hopes, beliefs, intentions or strategies regarding the future, and
statements that are not historical facts, including statements
about the clinical and therapeutic potential of our product
candidates, the availability and success of topline results from
our ongoing clinical trials and any commercial potential of our
product candidates following applicable regulatory approvals. In
addition, any statements that refer to projections, forecasts or
other characterizations of future events, results or circumstances,
including any underlying assumptions, are forward-looking
statements. Actual results may differ materially from those
contemplated in these statements due to a variety of risks,
uncertainties and other factors, including (i) the possibility that
the transaction may involve unexpected costs or liabilities, (ii)
the risk that disruptions from the transaction will harm
relationships with employees, customers and suppliers and other
business partners or (iii) the risk that the achievement of the
specified milestones or royalties described in the definitive
agreement for the transaction may take longer to achieve than
expected or may never be achieved and the resulting contingent
milestone payments or royalties may never be realized.
Although we believe that our plans, intentions, expectations and
strategies as reflected in or suggested by those forward-looking
statements are reasonable, we can give no assurance that the plans,
intentions, expectations or strategies will be attained or
achieved. Furthermore, actual results may differ materially from
those described in the forward-looking statements and will be
affected by a number of risks, uncertainties and assumptions,
including, but not limited to, those risks set forth in the Risk
Factors section of our filings with the U.S. Securities and
Exchange Commission. Moreover, we operate in a very competitive and
rapidly changing environment in which new risks emerge from time to
time. These forward-looking statements are based upon the current
expectations and beliefs of our management as of the date of this
press release, and are subject to certain risks and uncertainties
that could cause actual results to differ materially from those
described in the forward-looking statements. Except as required by
applicable law, we assume no obligation to update publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise.
1 Armstrong, A., Mehta, M., Schupp, C., Gondo, C., Bell, S.,
Griffiths, C. Psoriasis Prevalence in Adults in the United States.
JAMA Dermatol. 2021 Aug; 157(8):1-7.
doi:10.1001/jamadermatol.2021.2007
2 Eczema Prevalence. National Eczema Foundation. Eczema
Prevalence, Quality of Life and Economic Impact.
3 Carole, G., Corsin, S., Meienberger, N., Valeska Maul, L.,
Maul, J-T. The Impact of Gender and Sex in Psoriasis: What to be
Aware of When Treating Women with Psoriasis. Int J Women’s
Dermatol. 2022 Jun; 8(2): e010. doi: 10.1097/JW9.0000000000000010.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9112394/
4 Urban, K., Chu, S., Giesey, RL., Mehrmal, S., Uppal, P.,
Nedley, N., Delost, GR. The Global, Regional, and National Burden
of Atopic Dermatitis in 195 Countries and Territories: An
ecological study from the Global Burden of Disease Study 2017. 2021
Mar; 2: 12-18. JAAD International. doi:
https://doi.org/10.1016%2Fj.jdin.2020.10.002.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8362298/
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